NCT00167362

Brief Summary

This study will determine the effectiveness of cognitive enhancement therapy (CET) in treating cognitive abnormalities in people experiencing the early stages of schizophrenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

8 years

First QC Date

September 9, 2005

Last Update Submit

January 6, 2017

Conditions

Schizophrenia

Keywords

SchizophreniaCognitionEnhancementRandomized

Outcome Measures

Primary Outcomes (1)

  • Clinical, neuropsychological, and functional outcomes

    Measured at Years 1 and 3

Secondary Outcomes (1)

  • Neuroimaging parameters

    Measured at Year 2

Study Arms (2)

1

EXPERIMENTAL

Participants will receive cognitive enhancement therapy

Behavioral: Cognitive enhancement therapy (CET)

2

PLACEBO COMPARATOR

Participants will receive enriched supportive therapy

Behavioral: Enriched supportive therapy (EST)

Interventions

Cognitive enhancement therapy (CET)BEHAVIORAL

Using 80 to 100 hours of graduated exercises in computer assisted training, coupled with structured but unrehearsed in vivo social group interactions, CET tries to shift an early developmental reliance on effortful, serial and verbatim cognitive processing to a more gistful, less effortful and spontaneous abstraction of social themes. CET uses attention, memory and problem solving software from three exercises from Ben-Yishay's Orientation Remediation Module (the Attention Reaction Conditioner, Zero Accuracy Conditioner, and Time Estimates) that are graduated in difficulty and designed to enhance vigilance, selective attention, the ability to shift between auditory and visual modalities, and rapid decision-making.

1
Enriched supportive therapy (EST)BEHAVIORAL

EST is the commonly recommended (Spaulding 1992) treatment for control and experimental subjects in psychosocial trials. EST is a two-staged treatment that requires weekly one-hour sessions in Phase 1 and biweekly sessions in Phase 2. Some practice principles (e.g., psychoeducation and relaxation training) are provided during the group exercises for CET patients, but individually for EST patients. No attempt is made to control for hours of contact between EST and CET, since offering three hours of supportive therapy to EST subjects is neither logistically feasible nor faithful to the goals and methods of supportive therapy. Further, neurobiological hypotheses related to treatment specificity would be best tested by clear differences in treatment intensity and content.

2

Eligibility Criteria

Age16 Years - 51 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • DSM-IV diagnosis of schizophrenia, schizoaffective or schizophreniform disorder at the time of initial assessment
  • Pre-treatment illness duration an average of 5 years, not to exceed 8 years
  • Stable positive symptoms (e.g., if present do not grossly interfere with behavior such as command hallucinations or delusions)
  • Currently maintained and compliant with prescribed antipsychotic medication
  • Socially and cognitively disabled, e.g., meet criteria on a Cognitive Style Scale (score greater than or equal to 7), and Social Cognition Disability Scale (score greater than or equal to 12).

You may not qualify if:

  • Alcohol/drug abuse or dependence that has significantly interfered with adjustment in the past two months (e.g., patients currently undergoing D and A treatment must successfully complete their recovery program prior to referral)
  • Organic brain syndrome, including HIV illness (due to its effect on CNS function)
  • IQ below 80 or language skills below the sixth grade level
  • Medical contraindications that preclude an appropriate antipsychotic medication
  • Persistent suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (8)

  • Hogarty GE. Reinventing evidence-based interventions? Psychiatr Serv. 2005 Sep;56(9):1156; author reply 1156-7. doi: 10.1176/appi.ps.56.9.1156. No abstract available.

    PMID: 16148337BACKGROUND

  • Hogarty GE, Flesher S, Ulrich R, Carter M, Greenwald D, Pogue-Geile M, Kechavan M, Cooley S, DiBarry AL, Garrett A, Parepally H, Zoretich R. Cognitive enhancement therapy for schizophrenia: effects of a 2-year randomized trial on cognition and behavior. Arch Gen Psychiatry. 2004 Sep;61(9):866-76. doi: 10.1001/archpsyc.61.9.866.

    PMID: 15351765BACKGROUND

  • Hogarty GE. Medication adherence studies in schizophrenia. Am J Psychiatry. 2004 Mar;161(3):581-2; author reply 582-3. doi: 10.1176/appi.ajp.161.3.581-a. No abstract available.

    PMID: 14992994BACKGROUND

  • Hogarty GE. Cognitive rehabilitation of schizophrenia. Harv Ment Health Lett. 2000 Aug;17(2):4-6. No abstract available.

    PMID: 10927651BACKGROUND

  • Hogarty GE, Flesher S. Practice principles of cognitive enhancement therapy for schizophrenia. Schizophr Bull. 1999;25(4):693-708. doi: 10.1093/oxfordjournals.schbul.a033411.

    PMID: 10667740BACKGROUND

  • Keshavan MS, Hogarty GE. Brain maturational processes and delayed onset in schizophrenia. Dev Psychopathol. 1999 Summer;11(3):525-43. doi: 10.1017/s0954579499002199.

    PMID: 10532623BACKGROUND

  • Hogarty GE, Ulrich RF. The limitations of antipsychotic medication on schizophrenia relapse and adjustment and the contributions of psychosocial treatment. J Psychiatr Res. 1998 May-Aug;32(3-4):243-50. doi: 10.1016/s0022-3956(97)00013-7.

    PMID: 9793877BACKGROUND

  • Eack SM, Hogarty GE, Cho RY, Prasad KM, Greenwald DP, Hogarty SS, Keshavan MS. Neuroprotective effects of cognitive enhancement therapy against gray matter loss in early schizophrenia: results from a 2-year randomized controlled trial. Arch Gen Psychiatry. 2010 Jul;67(7):674-82. doi: 10.1001/archgenpsychiatry.2010.63. Epub 2010 May 3.

    PMID: 20439824DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Matcheri S Keshavan, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Gerard E Hogarty, MSW

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

August 1, 2001

Primary Completion

August 1, 2009

Study Completion

December 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

US(1)